Friedreich's Ataxia Market Poised for Rapid Expansion During the Forecast Period (2025-2034) as Drug Pipeline Gains Momentum
LAS VEGAS, June 5, 2025 /PRNewswire/ — DelveInsight's Friedreich's Ataxia Market Insights report includes a comprehensive understanding of current treatment practices, Friedreich's ataxia emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Friedreich's Ataxia Market Report
According to DelveInsight's analysis, the market size for Friedreich's ataxia is anticipated to surge at a significant rate by 2034.
The United States is expected to account for the highest market size of Friedreich's ataxia, of the total market size in 7MM in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
The prevalence of Friedreich's ataxia in the United States has been gradually increasing, reflecting greater awareness and improved diagnostic capabilities. Advances in genetic testing have allowed for earlier and more accurate identification of the condition, contributing to higher reported cases. Additionally, increased access to healthcare may facilitate more comprehensive assessments and documentation of rare diseases like Friedreich's ataxia. As research progresses, ongoing efforts to understand the genetic and environmental factors influencing this condition will be crucial for developing effective treatments and support systems for affected individuals.
Based on a secondary research genetically confirmed Friedreich's ataxia patient has not been found in the Japanese population, and the majority of patients with Friedreich's ataxia-like phenotype may be confirmed as AOA1, AOA2, ataxia with vitamin E deficiency or autosomal-recessive spastic ataxia of Charlevoix-Saguenay if examined by genetic testing.
Leading Friedreich's ataxia companies developing emerging therapies, such as Retrotope, PTC Therapeutics, Minoryx Therapeutics, Biogen, Lexeo Therapeutics, Larimar Therapeutics, Design Therapeutics, Solid Biosciences, and others, are developing novel Friedreich's ataxia drugs that can be available in the Friedreich's ataxia market in the coming years.
The promising Friedreich's ataxia therapies in the pipeline include RT001, Vatiquinone, Leriglitazone, Omaveloxolone, LX2006, nomlabofusp, SGT-212, and others.
Discover which therapies are expected to grab the Friedreich's ataxia therapeutics market share @ Friedreich's Ataxia Market Report
Friedreich's Ataxia Market Dynamics
The Friedreich's ataxia market dynamics are expected to change in the coming years. Advances in the understanding of Friedreich's ataxia have significantly clarified the role of frataxin and the disease's natural history, providing crucial insights that have guided the development of targeted therapeutic approaches aimed at addressing the underlying pathology.
The approval of omaveloxolone, a NF-E2-related factor 2 activator, by the FDA in 2023 and the EU in 2024, marks a milestone in disease-specific treatment. Concurrently, the rising prevalence of Friedreich's ataxia, driven by population growth and improved diagnostic technologies, is expected to fuel market demand. Meanwhile, biomarker development is progressing, with promising tools such as frataxin quantification and imaging biomarkers enhancing clinical trial sensitivity and enabling more precise patient stratification.
Furthermore, potential therapies are being investigated for the treatment of Friedreich's ataxia, and it is safe to predict that the treatment space will significantly impact the Friedreich's ataxia market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Friedreich's ataxia market in the 7MM.
However, several factors may impede the growth of the Friedreich's ataxia market. Progressive neurodegeneration in Friedreich's ataxia causes irreversible damage to the spinal cord, peripheral nerves, and cerebellum, leading to cumulative and disabling impairments; however, diagnostic delays due to reliance on clinical evaluation and genetic testing, especially in atypical or late-onset cases, combined with challenges in clinical trial design stemming from small patient populations, disease heterogeneity, and limited validated endpoints, as well as financial barriers such as high R&D costs and reimbursement hurdles, collectively complicate drug development and restrict patient access to emerging therapies.
Moreover, Friedreich's ataxia treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Friedreich's ataxia market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Friedreich's ataxia market growth.
Friedreich's Ataxia Treatment Market
Current treatments for Friedreich's ataxia primarily focus on alleviating specific symptoms rather than addressing the root cause of the disease. Despite advancements, symptom management continues to be the standard approach to care. While there is no cure, several strategies can help improve the quality of life for those affected.
The most serious complication, heart disease, can often be managed with medications commonly used in the general population, such as ACE inhibitors, beta-blockers, and diuretics, which help reduce cardiac strain. In cases of irregular heart rhythms, pacemakers or drugs may help stabilize heart function. Diabetes, another potential symptom, can be treated with insulin. Surgical interventions are occasionally required to address foot deformities or scoliosis; though significant, these procedures are generally effective.
Physical therapy plays a crucial role in maintaining muscle flexibility and mobility, while speech therapy can assist in improving communication and swallowing abilities by retraining facial and tongue muscles.
Emerging research targeting the root cause of Friedreich's ataxia focuses on frataxin, a protein involved in iron regulation and oxidative stress. Gene therapy approaches have shown potential, especially gene replacement strategies, although issues like targeted delivery, genotoxicity, and regulation of gene expression remain unresolved. Alternative approaches such as protein replacement using frataxin precursors or TAT-frataxin fusion proteins are also under investigation.
SKYCLARYS (omaveloxolone) is approved for treating Friedreich's ataxia in patients aged 16 and older, though its safety and effectiveness in younger individuals are still unknown. Omaveloxolone (RTA-408) is a semisynthetic oleanane triterpenoid with anti-inflammatory and antioxidant effects.
It activates the Nrf2 transcription factor, which is crucial for controlling oxidative stress, a function impaired in Friedreich's ataxia due to mitochondrial dysfunction. Enhancing Nrf2 activity through omaveloxolone may thus offer therapeutic benefits. In September 2023, Biogen finalized its acquisition of Reata Pharmaceuticals, the company behind omaveloxolone.
To know more about Friedreich's ataxia treatment options, visit @ Friedreich's Ataxia Medication
Friedreich's Ataxia Pipeline Therapies and Key Companies
Some of the drugs in the pipeline include RT001 (Retrotope), Vatiquinone (PTC Therapeutics), Leriglitazone (Minoryx Therapeutics), Omaveloxolone (Biogen), LX2006 (Lexeo Therapeutics), CTI-1601 (Larimar Therapeutics, Inc.), SGT-212 (Solid Biosciences), and others.
Vatiquinone, developed by PTC Therapeutics, is an experimental small molecule that targets 15-Lipoxygenase, an enzyme critically involved in regulating oxidative stress and inflammatory responses linked to neurological disorders. In March 2014, the U.S. FDA granted it Fast Track designation for treating Friedreich's ataxia, and it also holds Orphan Drug designation for the same condition. Currently, vatiquinone is in Phase III clinical trials for Friedreich's ataxia. In February 2025, the FDA accepted its New Drug Application (NDA) for the treatment of both pediatric and adult patients with Friedreich's ataxia, awarding it Priority Review with a PDUFA target action date of August 19, 2025.
RT001, developed by Retrotope, is a deuterated ethyl linoleate that inhibits lipid peroxidation, aiming to mitigate cellular damage and improve mitochondrial function. It received Fast Track status from the FDA in February 2021, and had earlier been granted Orphan Drug status in 2016 for Friedreich's ataxia. A Phase II/III trial evaluating its safety and efficacy in Friedreich's ataxia was completed in August 2021.
Leriglitazone, a product of Minoryx Therapeutics, is an orally active, selective PPARγ agonist with a promising profile for central nervous system (CNS) disorders. It was designated an Orphan Drug by both the FDA and EMA in 2019 for Friedreich's ataxia. Clinical evaluation in Phase II trials showed beneficial outcomes in patients with the condition.
The anticipated launch of these emerging therapies are poised to transform the Friedreich's ataxia market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Friedreich's ataxia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about Friedreich's ataxia treatment pipeline @ Friedreich's Ataxia Clinical Trials
Recent Developments in the Friedreich's Ataxia Market
In April 2025, Lexeo Therapeutics, Inc. reported encouraging interim results from all dose groups of LX2006 in the treatment of Friedreich ataxia cardiomyopathy. Data from both the Lexeo-sponsored SUNRISE-FA Phase 1/2 trial (NCT05445323) and the investigator-initiated Phase 1A trial at Weill Cornell Medicine (NCT05302271) showed that LX2006 led to meaningful improvements in cardiac biomarkers and functional outcomes. Additionally, all participants who underwent cardiac biopsies demonstrated increased frataxin protein expression.
In February 2025, the FDA accepted the New Drug Application (NDA) for vatiquinone, intended for the treatment of both children and adults with Friedreich's ataxia. The application has been granted Priority Review.
In January 2025, Solid Biosciences Inc. announced that the FDA has granted Fast Track designation to SGT-212, its AAV-based gene therapy candidate for treating Friedreich's ataxia.
Friedreich's Ataxia Overview
Friedreich's ataxia is a rare genetic disorder that results in progressive damage to the nervous system and problems with movement. It typically starts during childhood and gradually leads to worsening muscle coordination.
The condition is caused by a mutation in the FXN gene, which provides instructions for producing a protein called frataxin. People who inherit two faulty copies of this gene, one from each parent, develop the disease.
In atypical cases, Friedreich's ataxia is classified into two subtypes: late-onset FRDA (LOFA), which begins between the ages of 26 and 39, and very late-onset FRDA (VLOFA), which starts after age 40. Symptoms generally appear between the ages of 5 and 15, with the earliest signs often including difficulty walking, poor balance, and slurred or slow speech.
Diagnosing Friedreich's ataxia involves a detailed clinical evaluation, including a comprehensive physical examination to identify issues such as balance problems, loss of joint position sense, absent reflexes, and other neurological signs. In addition, genetic testing now offers a definitive method for confirming the diagnosis.
Friedreich's Ataxia Epidemiology Segmentation
The Friedreich's ataxia epidemiology section provides insights into the historical and current Friedreich's ataxia patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The Friedreich's ataxia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Diagnosed Prevalent Cases of Friedreich's Ataxia
Onset Type Diagnosed Prevalent Cases of Friedreich's Ataxia
Total Treated Cases of Friedreich's Ataxia
Friedreich's Ataxia Market Report Metrics
Details
Study Period
2020–2034
Coverage
7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and The United Kingdom, and Japan].
Key Friedreich's Ataxia Companies
Retrotope, PTC Therapeutics, Minoryx Therapeutics, Biogen, Lexeo Therapeutics, Larimar Therapeutics, Design Therapeutics, Solid Biosciences, Reata Pharmaceuticals, and others
Key Friedreich's Ataxia Therapies
RT001, Vatiquinone, Leriglitazone, Omaveloxolone, LX2006, nomlabofusp, SGT-212, SKYCLARYS, and others
Scope of the Friedreich's Ataxia Market Report
Therapeutic Assessment: Friedreich's Ataxia current marketed and emerging therapies
Friedreich's Ataxia Market Dynamics: Key Market Forecast Assumptions of Emerging Friedreich's Ataxia Drugs and Market Outlook
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's views, Analyst's views, Friedreich's Ataxia Market Access and Reimbursement
Download the report to understand which factors are driving Friedreich's ataxia market trends @ Friedreich's Ataxia Treatment Market
Table of Contents
1.
Friedreich's Ataxia Market Key Insights
2.
Friedreich's Ataxia Market Report Introduction
3.
Friedreich's Ataxia Market Overview at a Glance
4.
Friedreich's Ataxia Market Executive Summary
5.
Disease Background and Overview
6.
Friedreich's Ataxia Treatment and Management
7.
Friedreich's Ataxia Epidemiology and Patient Population
8.
Patient Journey
9.
Friedreich's Ataxia Marketed Drugs
10.
Friedreich's Ataxia Emerging Drugs
11.
Seven Major Friedreich's Ataxia Market Analysis
12.
Friedreich's Ataxia Market Outlook
13.
Potential of Current and Emerging Therapies
14.
KOL Views
15.
Unmet Needs
16.
SWOT Analysis
17.
Appendix
18.
DelveInsight Capabilities
19.
Disclaimer
20.
About DelveInsight
Related Reports
Friedreich's Ataxia Epidemiology Forecast
Friedreich's Ataxia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted Friedreich's ataxia epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Friedreich's Ataxia Pipeline
Friedreich's Ataxia Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Friedreich's ataxia companies, including PTC Therapeutics, Retrotope, Reata Pharmaceuticals, Minoryx Therapeutics, Larimar Therapeutics, LEXEO Therapeutics, Exicure, StrideBio, Voyager Therapeutics, Lacerta Therapeutics, among others.
Ataxia Market
Ataxia Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key ataxia companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, among others.
Ataxia Pipeline
Ataxia Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ataxia companies, including Retrotope, Reata Pharmaceuticals, PTC Therapeutics, Metro International Biotech, LLC, Design Therapeutics, Larimar Therapeutics, Minoryx Therapeutics, EryDel, Biogen, Matrix Biomed, IntraBio, Biohaven Pharmaceuticals, Inc., Stealth BioTherapeutics Inc., Acasti Pharma, Seelos Therapeutics, Kissei Pharmaceutical, Vico Therapeutics, Q-State Biosciences, Locanabio, Lexeo Therapeutics, Voyager Therapeutics, CRISPR Therapeutics, Capsida Biotherapeutics, AavantiBio, StrideBio, Wave Life Sciences, REPROCELL, SHIONOGI & Co., CORESTEM, Blade Therapeutics, Exicure, Lacerta Therapeutics, Healx Ltd., Uniqure, Ionis Pharmaceuticals, Jupiter Neurosciences, among others.
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
Contact UsShruti Thakur [email protected] +14699457679www.delveinsight.com
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- Malaysian Reserve
Progressive Supranuclear Palsy Market on Upward Trajectory During the Forecast Period (2025-2034) with Emerging Immunotherapies
The progressive supranuclear palsy market is expected to witness steady growth due to increasing disease awareness, advancements in diagnostic tools, and ongoing clinical research focused on disease-modifying therapies. Rising prevalence of neurodegenerative disorders, coupled with the aging global population, is driving the demand for novel treatments. LAS VEGAS, Aug 7, 2025 /PRNewswire/ — DelveInsight's Progressive Supranuclear Palsy Market Insights report includes a comprehensive understanding of current treatment practices, progressive supranuclear palsy emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Progressive Supranuclear Palsy Market Report According to DelveInsight's analysis, the market size for progressive supranuclear palsy in the 7MM is expected to grow significantly by 2034. The United States accounted for the highest progressive supranuclear palsy treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Approximately one in every 100,000 individuals over the age of 60 is affected by progressive supranuclear palsy. Among all the phenotype-specific cases of PSP, Richardson's syndrome accounted for more than 50% of cases in 2024. Leading progressive supranuclear palsy companies developing emerging therapies, such as Amylyx Pharmaceuticals, AlzProtect, Transposon Therapeutics, Ferrer, Asceneuron, UCB Biopharma, Novartis, and others, are developing new progressive supranuclear palsy treatment drugs that can be available in the progressive supranuclear palsy market in the coming years. The promising progressive supranuclear palsy therapies in the pipeline include AMX0035, AZP2006, TPN-101, FNP-223/ASN90, Bepranemab (UCB0107), NIO752, and others. Discover the progressive supranuclear palsy new treatment @ New Treatments for Progressive Supranuclear Palsy Progressive Supranuclear Palsy Market Dynamics The progressive supranuclear palsy market dynamics are expected to change in the coming years. The progressive supranuclear palsy market is driven by increasing disease awareness, advancements in diagnostic technologies, and growing research efforts to develop disease-modifying therapies. Rising prevalence of neurodegenerative disorders, particularly among the aging population, is further fueling the demand for effective PSP treatment options. Strategic collaborations between pharmaceutical companies and research institutions are accelerating drug discovery and clinical trials, while regulatory incentives such as orphan drug designations are encouraging innovation in this rare disease space. Additionally, the growing adoption of advanced imaging techniques and biomarker-based diagnostics is enabling early and accurate diagnosis, creating a favorable environment for therapeutic interventions and market growth. As potential therapies are being investigated for the treatment of progressive supranuclear palsy, it is safe to predict that the treatment space will significantly impact the progressive supranuclear palsy market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the progressive supranuclear palsy market in the 7MM. However, several factors may impede the growth of the progressive supranuclear palsy market. A major challenge is the limited understanding of the disease's underlying pathophysiology, which complicates the identification of viable therapeutic targets. The small patient population and the rarity of PSP restrict the scope of clinical trials, leading to high costs, longer timelines, and recruitment difficulties. Additionally, the absence of disease-modifying treatments and reliance on symptomatic therapies limit market growth, as current treatment options provide only minimal clinical benefit. Regulatory hurdles, stringent approval processes, and a high failure rate in late-stage clinical trials further exacerbate the challenges. Moreover, the lack of robust diagnostic tools and biomarkers often delays early diagnosis, reducing the potential for timely interventions and effective disease management. Progressive Supranuclear Palsy Treatment Market At present, no approved medications or standardized clinical guidelines exist specifically for the treatment of progressive supranuclear palsy. Management focuses on alleviating symptoms, providing supportive care, and enhancing the patient's quality of life. Drugs commonly prescribed for Parkinson's disease, such as levodopa, may offer some relief from motor symptoms like rigidity, tremors, and bradykinesia, but their effectiveness in PSP is generally limited and short-lived. Dopamine agonists, including amantadine and ropinirole, can be used alone or in combination with levodopa, though they provide only modest benefits. Beyond medications, a multidisciplinary care approach is crucial. Physical therapy aids in improving mobility and balance, occupational therapy assists with daily activities, and speech and swallowing therapy helps manage communication and feeding challenges. These supportive strategies play a key role in preserving the best possible quality of life for PSP patients. To know more about progressive supranuclear palsy treatment options, visit @ Approved Progressive Supranuclear Palsy Drugs Progressive Supranuclear Palsy Pipeline Therapies and Key Companies The emerging pipeline for PSP includes AZP2006 (AlzProtect), AMX0035 (Amylyx Pharmaceuticals), TPN-101 (Transposon Therapeutics), FNP-223 (Ferrer), and others. AZP2006 is an orally administered small molecule featuring a unique mechanism of action. It acts through a neurotrophic factor, offering enhanced neuroprotective effects combined with anti-inflammatory activity in the nervous system. This compound shows significant therapeutic promise for addressing the underlying pathological mechanisms of progressive supranuclear palsy (PSP) and other tau-related disorders, including Alzheimer's disease. In September 2024, the company announced the successful completion of a Phase IIa clinical trial of AZP2006 for PSP treatment. Throughout a 3-month Phase IIa study in PSP patients, the drug demonstrated promising clinical and biomarker efficacy signals. These findings were further corroborated by results from a 6-month open-label extension study, strengthening its therapeutic potential. AZP2006 has also been granted Orphan Drug Designation by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In April 2025, the Progressive Supranuclear Palsy (PSP) Trial Platform (PTP), led by Drs. Adam Boxer (University of California, San Francisco), Irene Litvan (University of California, San Diego), Julio Rojas (UCSF), and Anne-Marie Wills (Massachusetts General Hospital), selected two promising drug candidates, Axon Neuroscience's AADvac1 and Alzprotect's AZP2006, as the first compounds to be tested under the platform trial. This initiative aims to accelerate the development of effective treatments for PSP, a rare and fatal neurodegenerative disorder. AMX0035 is an oral, fixed-dose combination therapy composed of sodium phenylbutyrate and taurursodiol (also known as ursodoxicoltaurine). It has a strong mechanistic rationale for PSP, targeting critical upstream pathways involved in disease pathogenesis, such as the unfolded protein response and mitochondrial dysfunction. Additionally, AMX0035 has been shown to lower p-tau levels in Alzheimer's disease studies. Currently, AMX0035 is being evaluated in a global Phase IIb/III (ORION) clinical trial, which aims to determine its efficacy, safety, and tolerability in PSP patients. The trial is expected to conclude by April 2026, with Amylyx Pharmaceuticals planning to release safety and efficacy data from the unblinded Phase IIb portion of the study in Q3 2025. The anticipated launch of these emerging therapies are poised to transform the progressive supranuclear palsy market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the progressive supranuclear palsy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about progressive supranuclear palsy marketed and pipeline drugs @ Progressive Supranuclear Palsy Clinical Trials Recent Developments in the Progressive Supranuclear Palsy Market In June 2025, Ferrer announced that the US FDA has granted the Fast Track designation to FNP-223 for treatment of patients with progressive supranuclear palsy (PSP). In April 2025, AlzProtect's AZP2006 was chosen as one of the initial two therapies to be tested in the newly launched national Phase II Platform Trial for Progressive Supranuclear Palsy (PSP) in the United States. Funded by the National Institute on Aging (NIH), the trial aims to fast-track the development of effective treatments for PSP. Progressive Supranuclear Palsy Overview Progressive supranuclear palsy is a rare neurodegenerative disorder that affects movement, balance, speech, and eye movements. It is caused by the accumulation of abnormal tau protein in certain areas of the brain, leading to the degeneration of nerve cells. While the exact cause of PSP is not fully understood, it is believed to involve a combination of genetic and environmental factors. PSP typically affects individuals over the age of 60 and progresses gradually over time. The symptoms of PSP include difficulties with balance and frequent falls, stiffness and slow movements similar to Parkinson's disease, and problems with eye movements, particularly the inability to move the eyes up and down. Other symptoms may include speech and swallowing difficulties, personality changes, irritability, depression, and cognitive decline. Unlike Parkinson's disease, tremors are uncommon in PSP, which helps in differentiating the two conditions. Diagnosis of PSP is challenging as there is no specific test to confirm the condition. It is primarily diagnosed based on clinical symptoms, neurological examinations, and the exclusion of other similar conditions. Brain imaging techniques, such as MRI, may reveal characteristic brain changes like midbrain shrinkage, which supports the diagnosis. Early recognition of eye movement abnormalities and postural instability is crucial for an accurate diagnosis. Progressive Supranuclear Palsy Epidemiology Segmentation The progressive supranuclear palsy epidemiology section provides insights into the historical and current progressive supranuclear palsy patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The progressive supranuclear palsy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of PSP Total Diagnosed Prevalent Cases of PSP Gender-specific Diagnosed Prevalent Cases of PSP Phenotype-specific Diagnosed Prevalent Cases of PSP Comorbidity Associated Cases with PSP Progressive Supranuclear Palsy Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and The United Kingdom, and Japan]. Key Progressive Supranuclear Palsy Companies Amylyx Pharmaceuticals, AlzProtect, Transposon Therapeutics, Ferrer, Asceneuron, UCB Biopharma, Novartis, and others Key Progressive Supranuclear Palsy Therapies AMX0035, AZP2006, TPN-101, FNP-223/ASN90, Bepranemab (UCB0107), NIO752, and others Scope of the Progressive Supranuclear Palsy Market Report Therapeutic Assessment: Progressive Supranuclear Palsy current marketed and emerging therapies Progressive Supranuclear Palsy Market Dynamics: Key Market Forecast Assumptions of Emerging Progressive Supranuclear Palsy Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Progressive Supranuclear Palsy Market Access and Reimbursement Download the report to understand which factors are driving progressive supranuclear palsy therapeutics market trends @ Progressive Supranuclear Palsy Market Trends Table of Contents 1. Progressive Supranuclear Palsy Market Key Insights 2. Progressive Supranuclear Palsy Market Report Introduction 3. Progressive Supranuclear Palsy Market Overview at a Glance 4. Progressive Supranuclear Palsy Market Executive Summary 5. Disease Background and Overview 6. Progressive Supranuclear Palsy Treatment and Management 7. Progressive Supranuclear Palsy Epidemiology and Patient Population 8. Patient Journey 9. Progressive Supranuclear Palsy Marketed Drugs 10. Progressive Supranuclear Palsy Emerging Drugs 11. Seven Major Progressive Supranuclear Palsy Market Analysis 12. Progressive Supranuclear Palsy Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Progressive Supranuclear Palsy Pipeline Progressive Supranuclear Palsy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PSP companies, including Amylyx Pharmaceuticals, Transposon Therapeutics, Inc., Ferrer International, Novartis Pharmaceuticals, TauC3 Biologics, among others. Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, LLC, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies including AB Science, Alzheon Inc., AriBio Co., Ltd., AgeneBio, Inc., Anavex Life Sciences Corp., Annovis Bio, Inc., Cerecin, BioVie, Cassava Sciences, Novo Nordisk, Eli Lilly, Neurim Pharmaceuticals, Suven Life Sciences, Bristol-Myers Squibb, Karuna Therapeutics, T3D Therapeutics, Inc., Lexeo Therapeutics, Axsome Therapeutics, Inc., Araclon Biotech S.L., Eisai Co., Ltd., TauRx Therapeutics, TrueBinding, Inc., AC Immune SA, Johnson & Johnson, Longeveron Inc., Vaccinex Inc., IGC Pharma LLC, among others. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies including Eisai Co., Ltd., Eli Lilly and Company, Novartis AG, DAIICHI SANKYO COMPANY, LIMITED, AbbVie Inc., Lundbeck, Biogen, Cipla, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ + Logo: View original content:
Malaysian Reserve
07-08-2025
- Malaysian Reserve
FAP Inhibitors Market Analysis Across the 7MM: Key Insights and Outlook Through 2040
According to DelveInsight's analysis, the growth of the FAP inhibitor market is expected to be primarily driven by the anticipated launch of several emerging therapies such as [18F] FAPI-74, [68Ga] FAPI-46, AZD2389, BXCL701, AVA6000, and others targeting a range of indications. LAS VEGAS, Aug 7, 2025 /PRNewswire/ — DelveInsight's FAP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as NSCLC, Ovarian cancer, Pancreatic cancer, Metastatic colorectal cancer, Prostate cancer, Triple-negative breast cancer, Soft tissue sarcoma, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging FAP inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2040, segmented into 7MM. Key Takeaways from the FAP Inhibitors Market Report As per DelveInsight's analysis, the total market size of FAP inhibitors in the 7MM is expected to surge significantly by 2040. The report provides the total potential number of patients in the indications, such as NSCLC, Ovarian cancer, Pancreatic cancer, Metastatic colorectal cancer, Prostate cancer, Triple-negative breast cancer, Soft tissue sarcoma, and others. Leading FAP inhibitor companies, such as SOFIE, BioXcel, OnkosXcel, AstraZeneca, Avacta, and others, are developing novel FAP inhibitors that can be available in the FAP inhibitors market in the coming years. Some of the key FAP inhibitors in the pipeline include [18F]FAPI-74, [68Ga]FAPI-46, BXCL701, AZD 2389, AVA6000, and others. In March 2025, Avacta announced promising early efficacy and safety data for AVA6000 in the Phase Ia Dose Escalation and ongoing enrollment in the Phase Ib Expansion Cohorts. In February 2024, BioXcel Therapeutics received US FDA Fast Track Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability. Discover which indication is expected to grab the major FAP inhibitors market share @ FAP Inhibitors Market Report FAP Inhibitors Market Dynamics The FAP inhibitors market is gaining momentum as the understanding of FAP's role in various pathological conditions, particularly cancer and fibrosis, continues to evolve. FAP is highly expressed in cancer-associated fibroblasts (CAFs) within the tumor microenvironment and in fibrotic tissues, but is largely absent in normal adult tissues. This selective expression profile has made FAP an attractive target for therapeutic intervention, as it allows for more precise targeting of tumor stroma or fibrotic lesions with reduced off-target effects. As a result, the FAP inhibitor landscape is witnessing increased research and development activities from both pharmaceutical companies and academic institutions. Market growth is being fueled by multiple clinical programs evaluating FAP inhibitors in oncology, particularly in solid tumors such as pancreatic, breast, lung, and colorectal cancers. These inhibitors are being studied both as monotherapies and in combination with other agents like immune checkpoint inhibitors and chemotherapeutics. Several radiolabeled FAP inhibitors are also advancing in the diagnostics space, especially in PET imaging, offering real-time assessment of tumor burden and stromal activity. The dual diagnostic and therapeutic potential (theranostics) of FAP-targeting agents enhances their market appeal, with companies seeking to develop companion diagnostics and targeted radioligand therapies. Despite the promising potential, challenges persist in optimizing the pharmacokinetics, safety profiles, and therapeutic windows of FAP inhibitors. Many compounds in development are still in early- to mid-stage clinical trials, and efficacy data remain limited. Additionally, while FAP overexpression is common across various tumors, patient stratification and biomarker-driven approaches will be critical for successful commercialization. Addressing these challenges through improved drug design and clinical validation will be key to unlocking the full potential of this drug class. From a competitive standpoint, the market is moderately fragmented, with a mix of biotech startups and large pharmaceutical companies pursuing differentiated approaches. Some developers are focusing on small molecules, while others are leveraging antibody-drug conjugates (ADCs), bispecific antibodies, or FAP-targeted radiopharmaceuticals. Strategic collaborations, licensing deals, and academic partnerships are becoming common, as companies seek to access novel platforms and reduce development risk. This dynamic landscape suggests significant potential for innovation, particularly in niche indications where conventional therapies have limited efficacy. In the coming years, the FAP inhibitors market is expected to benefit from growing interest in tumor microenvironment modulation, expanding applications in fibrotic diseases, and increased investment in precision medicine. Regulatory pathways for novel cancer and fibrosis therapeutics continue to evolve, potentially accelerating time-to-market for promising FAP-targeted agents. With no approved therapies currently available, the first entrants into the market stand to capture substantial value, especially if they demonstrate meaningful clinical benefit in underserved patient populations. FAP Inhibitors Treatment Market FAPI belongs to a novel class of tracers with emerging roles in cancer diagnosis and therapy. Clinical trials are actively investigating the safety and efficacy of FAP inhibitors for both oncologic and fibrotic conditions, with several candidates advancing into mid-stage trials. Currently, no FAP inhibitors have received regulatory approval. While challenges remain, such as enhancing drug delivery and reducing toxicity, FAP-targeted therapies represent a promising step forward in precision treatment for cancer and fibrotic diseases. Continued research and clinical validation could position FAP inhibitors as an innovative option for patients with these complex conditions. FAP has gained recognition as a specific biomarker for carcinoma-associated fibroblasts (CAFs) and activated fibroblasts found in tissues undergoing extracellular matrix (ECM) remodeling due to persistent inflammation, fibrosis, or tissue repair. FAPI agents have been studied extensively across multiple tumor types, in both diagnostic imaging and therapeutic applications. The tumor microenvironment (TME), predominantly consisting of ECM components like blood vessels, cytokines, growth factors, and fibroblasts, plays a central role in cancer development. Fibroblasts contribute to collagen synthesis and modulate local inflammatory and homeostatic processes. A specialized subgroup, myofibroblasts, exhibits contractile features similar to smooth muscle cells. In colorectal cancer, FAP overexpression in fibroblasts has been associated with poor prognosis, including increased lymph node involvement, tumor recurrence, angiogenesis, and decreased overall survival. Learn more about the FAP inhibitors @ FAP Inhibitors Analysis Key Emerging FAP Inhibitors and Companies Key players in the FAP inhibitor market include AstraZeneca (AZD 2389), Sofie ([18F]FAPI-74; [68Ga]FAPI-46), BioXcel/OnkosXcel (BXCL701), Avacta Life Science (AVA6000), and several other companies. A radiopharmaceutical known as [18F] FAPI-74 combines FAPI-74, a quinoline-based compound that targets fibroblast activation protein (FAP), with the chelating agent NOTA (1,4,7-triazacyclononane-N,N',N'-triacetic acid), and is labeled with the positron-emitting isotope fluorine-18. It is designed for PET imaging of tumors and cancer-associated fibroblasts (CAFs) that express FAP. After administration, FAPI-74 binds to FAP-expressing tumor cells and CAFs. These bound cells can then be visualized via PET scans. FAP is a surface protein highly expressed in many cancers and in CAFs within the tumor microenvironment (TME). A Phase II clinical trial (NCT05641896) is underway to evaluate [18F] FAPI-74 PET imaging in patients with gastrointestinal cancers. This study is multicenter, single-arm, open-label, and non-randomized. In October 2023, SOFIE and GE HealthCare entered into a licensing agreement for the development and commercialization of [68Ga] FAPI-46 and [18F] FAPI-74. Under this deal, GE HealthCare acquired global rights to [68Ga] FAPI-46 and ex-U.S. rights to [18F] FAPI-74, while SOFIE retained U.S. rights for [18F] FAPI-74's clinical development and commercialization. AVA6000, a prodrug of the chemotherapy agent doxorubicin, functions by inhibiting an enzyme that promotes cancer cell growth. Unlike standard doxorubicin, AVA6000 remains inactive until it reaches tumor tissue, potentially reducing side effects. It is administered intravenously. On January 16, 2025, Avacta reported encouraging results from its Phase I trial of AVA6000. In patients with salivary gland cancer, five out of ten showed tumor shrinkage—ranging from partial to minor responses—with a disease control rate of 90%. The anticipated launch of these emerging therapies are poised to transform the FAP inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the FAP inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about FAP inhibitors clinical trials, visit @ FAP Inhibitors Treatment FAP Inhibitors Overview Fibroblast activation protein (FAP) is a type II transmembrane serine protease predominantly found on activated fibroblasts, especially within the tumor microenvironment and areas of tissue remodeling. It is largely absent in healthy adult tissues but becomes markedly upregulated in more than 90% of epithelial cancers, where it plays a key role in promoting tumor progression by remodeling the extracellular matrix, supporting angiogenesis, suppressing immune responses, and aiding tumor cell invasion. Elevated levels of FAP are also observed in various fibrotic and inflammatory conditions, including liver cirrhosis, pulmonary fibrosis, rheumatoid arthritis, and during wound healing, emphasizing its broader involvement in pathological tissue remodeling. Because of its disease-restricted expression and functional significance, FAP has gained traction as a target for diagnostic and therapeutic applications. Radiolabeled FAP inhibitors (FAPIs) have delivered strong results in PET imaging by offering high-contrast visualization of tumors and fibrotic tissues with minimal background interference. These promising outcomes have led to the development of FAP-targeted treatments such as radioligand therapies, antibody-drug conjugates, and CAR T-cell approaches designed to modulate the tumor stroma and boost anti-cancer activity. Nevertheless, challenges remain, particularly in achieving specificity over related proteases and managing potential side effects in fibrotic conditions. Current research efforts are focused on optimizing FAPI pharmacokinetics, enhancing therapeutic effectiveness, and evaluating synergistic strategies with immunotherapies. Notably, FAP-targeted imaging and treatment approaches are expanding beyond oncology into fields like cardiology, pulmonology, and autoimmune disease, underscoring its growing importance as a biomarker and therapeutic target with the potential to transform precision medicine for both cancer and fibrotic disorders. FAP Inhibitors Epidemiology Segmentation The FAP inhibitors market report proffers epidemiological analysis for the study period 2020–2040 in the 7MM, segmented into: Total Cases in Selected Indications for FAP Inhibitor Total Eligible Patient Pool in Selected Indications for FAP Inhibitor Total Treated Cases in Selected Indications for FAP Inhibitor FAP Inhibitors Report Metrics Details Study Period 2020–2040 FAP Inhibitors Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report NSCLC, Ovarian cancer, Pancreatic cancer, Metastatic colorectal cancer, Prostate cancer, Triple-negative breast cancer, Soft tissue sarcoma, and others Key FAP Inhibitors Companies SOFIE, BioXcel, OnkosXcel, AstraZeneca, Avacta, and others Key FAP Inhibitors [18F]FAPI-74, [68Ga]FAPI-46, BXCL701, AZD 2389, AVA6000, and others Scope of the FAP Inhibitors Market Report FAP Inhibitors Therapeutic Assessment: FAP Inhibitors' current marketed and emerging therapies FAP Inhibitors Market Dynamics: Conjoint Analysis of Emerging FAP Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, FAP Inhibitors Market Access and Reimbursement Discover more about FAP inhibitors in development @ FAP Inhibitors Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary of FAP Inhibitor 4. Key Events 5. Epidemiology and Market Forecast Methodology 6. FAP Inhibitor Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2024 6.2. Market Share (%) Distribution by Therapies in 2040 6.3. Market Share (%) Distribution by Indications in 2024 6.4. Market Share (%) Distribution by Indications in 2040 7. FAP Inhibitor: Background and Overview 7.1. Introduction 7.2. Potential of FAP Inhibitor in Different Indications 7.3. Clinical Applications of FAP Inhibitor 8. FAP Target Patient Pool 8.1. Key Findings 8.2. Assumptions and Rationale: 7MM 8.3. Epidemiology Scenario in the 7MM 8.4. Total Cases in Selected Indications for FAP Inhibitor in the 7MM 8.5. Total Eligible Patient Pool for FAP Inhibitor in Selected Indications in the 7MM 8.6. Total Treated Cases in Selected Indications for FAP Inhibitor in the 7MM 9. Emerging Therapies 9.1. Key Competitors 9.2. [ F]FAPI-74: SOFIE 9.2.1. Product Description 9.2.2. Other developmental activities 9.2.3. Clinical development 9.2.4. Safety and efficacy 9.2.5. Analyst Views 9.3. AVA6000: Avacta List to be continued in the report 10. FAP Inhibitor: Seven Major Market Analysis 10.1. Key Findings 10.2. Market Outlook 10.3. Conjoint Analysis 10.4. Key Market Forecast Assumptions 10.4.1. Cost Assumptions and Rebates 10.4.2. Pricing Trends 10.4.3. Analogue Assessment 10.4.4. Launch Year and Therapy Uptakes 10.5. Total Market Size of FAP Inhibitor in the 7MM 10.6. Market Size of FAP Inhibitor by Indication in the 7MM 10.7. The United States 10.8. EU4 and the UK 10.9. Japan 11. Market Access and Reimbursement 12. SWOT Analysis 13. KOL Views 14. Unmet Needs 15. Bibliography 16. Report Methodology Related Reports Prostate Cancer Market Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key prostate cancer companies, including Janssen Research and Development, Sanofi, Astellas Pharma, Bayer, Novartis, Curium, Merck, Orion, Pfizer, Exelixis, Ipsen Pharma, Takeda, AB Science, Lantheus, Eli Lilly, POINT Biopharma, Telix Pharmaceuticals, Tavanta Therapeutics, Jiangsu Hengrui Pharmaceuticals, Kangpu Biopharmaceuticals, Fusion Pharma, Merus, Bristol-Myers Squibb, Syntrix Pharmaceuticals, Promontory Therapeutics, Xencor, Taiho Pharmaceutical, Madison Vaccines, MacroGenics, Zenith Epigenetics, Modra Pharmaceuticals, Arvinas, Laekna Therapeutics, Blue Earth Therapeutics, Oncternal Therapeutics, Essa Pharma, Clarity Pharmaceuticals, BioNTech and DualityBio, Daiichi Sankyo, Fortis Therapeutics, ORIC Pharmaceuticals, Amgen, among others. Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Takeda, Johnson & Johnson Innovative Medicine, Eli Lilly and Company, Merck, Bristol-Myers Squibb, Roche, Shanghai Henlius Biotech, AbbVie, Daiichi Sankyo, Nuvation Bio, PDC*line Pharma, Moderna Therapeutics, Pfizer, GSK, Gilead Sciences, BieGene, Nuvalent, among others. Metastatic Colorectal Cancer Market Metastatic Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic colorectal cancer companies, including Johnson & Johnson Innovative Medicine, Shanghai Henlius Biotech, Inspirna, Treos Bio, Cardiff Oncology, Agenus, Leap Therapeutics, Arcus Biosciences, Enterome, Tizona Therapeutics, Innovative Cellular Therapeutics, among others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, Celgene, BioLineRx, Alligator Bioscience, Bellicum Pharmaceuticals, OSE Immunotherapeutics, Actuate Therapeutics, FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, Merus, Mirati Therapeutics, Rexahn Pharmaceuticals, Ocuphire Pharma, Processa Pharmaceuticals, ImmunityBio, Berg, Panbela Therapeutics, GlaxoSmithKline, Eleison Pharmaceuticals, Molecular Templates, Lokon Pharma AB, Cantargia AB, Bristol-Myers Squibb, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:
